CDSCO Approved · NABL Accredited · USFDA Registered

CDSCO Approved Testing Laboratory India | Medical Device & Pharma Testing

Auriga Research operates a CDSCO (Central Drugs Standard Control Organisation) approved testing laboratory in India for pharmaceutical, medical device, and cosmetic product testing. Our test reports are accepted by CDSCO for new drug applications, medical device registrations, import licences, and regulatory compliance documentation.

The laboratory holds concurrent NABL accreditation under ISO/IEC 17025:2017 and USFDA registration, providing test data that meets both Indian and international regulatory requirements. Our analytical capabilities span chemical testing, microbiological analysis, biocompatibility studies, stability testing, and extractable/leachable analysis.

With over 700 scientists and technical staff across five laboratory facilities, Auriga Research provides the testing infrastructure, regulatory knowledge, and turnaround speed that pharmaceutical and medical device companies need for timely market access in India.

Request Testing Quote Call +91-7428116100

Laboratory Accreditations

Multi-accredited facility providing test data accepted by Indian and international regulatory authorities.

CDSCO

Approved for pharmaceutical and medical device testing

NABL

Accredited under ISO/IEC 17025:2017

USFDA

Registered facility for FDA-accepted testing

700+

Scientists and technical staff across 5 labs

Testing Services Under CDSCO Approval

Comprehensive testing capabilities for regulated products requiring CDSCO-accepted test data.

Pharmaceutical Testing

Assay, dissolution, impurity profiling, content uniformity, stability studies (ICH), and microbiological testing per IP, USP, BP, and EP pharmacopoeias.

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Medical Device Testing

Biocompatibility testing per ISO 10993, extractables and leachables, sterility, particulate matter, chemical characterisation, and performance testing.

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Cosmetics & Personal Care

Heavy metals, preservative efficacy, microbiological limits, stability, pH, viscosity, and safety testing for cosmetic product notifications.

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Stability Studies

ICH-aligned long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate stability studies with zone IV conditions for tropical markets.

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Microbiological Analysis

Sterility testing, microbial limits, endotoxin (LAL), preservative efficacy, bioburden, and environmental monitoring per pharmacopoeial methods.

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CRO Services

CDSCO-approved clinical research including Phase I-III trials, bioanalytical testing, pharmacovigilance, and medical writing for regulatory submissions.

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Regulatory Submissions We Support

Pharmaceutical

  • ✓ New drug applications (NDA)
  • ✓ Import licence applications
  • ✓ Manufacturing licence applications
  • ✓ Post-marketing surveillance testing
  • ✓ Batch release testing

Medical Devices

  • ✓ Device registration (MDR 2017)
  • ✓ Biocompatibility evaluation reports
  • ✓ Import and manufacturing licences
  • ✓ Performance and safety testing
  • ✓ Shelf life and ageing studies

Other Accreditations & Approvals

NABL Accredited Lab ISO/IEC 17025:2017 accreditation USFDA Registered Lab FDA registration for testing FSSAI Approved Lab Food safety testing Medical Device Testing Biocompatibility, safety Pharmaceutical Testing Analytical, stability, micro CRO Services Clinical trials, pharmacovigilance

Frequently Asked Questions

What does CDSCO approved laboratory mean?
A CDSCO (Central Drugs Standard Control Organisation) approved laboratory is a testing facility authorised by India's apex drug regulatory authority to conduct testing of pharmaceuticals, medical devices, cosmetics, and other regulated products. CDSCO approval confirms that the laboratory meets the infrastructure, equipment, personnel, and quality management standards required for generating data that regulatory authorities accept for product approvals, market authorisations, and compliance certifications.
What types of products can a CDSCO approved lab test?
A CDSCO approved laboratory can test pharmaceuticals (drug products and drug substances), medical devices (biocompatibility, safety, performance), cosmetics and personal care products, biologicals, and in-vitro diagnostics. Auriga Research's CDSCO approved laboratory conducts pharmaceutical testing (dissolution, assay, impurities, stability), medical device testing (biocompatibility per ISO 10993, extractables, sterility), and cosmetic product testing for regulatory submissions.
How are CDSCO test reports used in regulatory submissions?
CDSCO test reports from approved laboratories are used in new drug applications, medical device registration (under Medical Device Rules, 2017), import licence applications, manufacturing licence applications, and post-marketing compliance documentation. Test data from a CDSCO approved lab carries regulatory weight and is accepted by CDSCO reviewers without additional validation. Auriga Research provides test reports formatted for direct inclusion in regulatory submission dossiers.

Get CDSCO-Accepted Test Reports

CDSCO approved laboratory with NABL accreditation and USFDA registration. Pharmaceutical, medical device, and cosmetic product testing for regulatory submissions.

+91-7428116100 Request Testing Quote

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